510(k) K860693 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
PULMANEX (TM)
| Applicant | Life Design Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Mar 27, 1986 |
| Received | Feb 25, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860693
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.